SAS Stability Coordinator

Function Summary  The SAS Stability coordinator is accountable to the Stability and Analytical Services Manager and is mainly responsible for managing the Stability program, preparing and maintaining technical documents such as protocols, specifications, reports, and SOPs and review of stability data at Novocol Cambridge.
Primary Duties and Responsibilities   Manages stability program and ensures all stability studies are started in a timely manner.
Prepares master schedule for stability studies and updates it with new studies.
Generates, manages and supports stability testing schedule.
Monitors production schedule on a weekly basis and requests samples for stability program.
Supports studies related to the post‑approval changes and maintains product life cycle.
Ensures bulk, finished product, validation and stability samples are logged and received in the lab.
Prepares and updates stability protocols and specifications in the Electronic Management System (Ennov and LIMS).
Logs, creates, starts new stability studies and retests in Electronic Management System (LIMS).
Prepares and verifies inventory cards and study requests.
Reviews and receives pulled stability sample(s), prints worksheets.
Monitors testing progress of stability sample(s) in LIMS to ensure timely testing and data entry.
Reviews stability data and ensures all results meet stability trend.
Manages stability chambers and initiates investigations for temperature and humidity excursions.
Troubleshoots alarms on stability chambers and contacts vendors for chamber repairs.
Prepares and supports Annual Product Quality Review (APQR) for FDA for US/CA/INT markets.
Prepares annual product review reports and assists during regulatory audits.
Communicates with vendors, requests quotations, creates purchase orders, receives invoices and initiates work orders in Electronic Management System (AX and CARL).
Provides stability data and stability trends to regulatory affairs department as required.
Prepares and supports preparation of PowerPoint decks for monthly group meetings.
Provides AX training to SAS, PD and QC staff (as required).
Supports data review and service group release (as required).
Initiates and supports DCR/CCR related to stability studies.
Demonstrates the Company Mission, Vision and Values Statements, policies, and current standard business practices.
Observes and supports all safety guidelines and regulations.
Performs other related duties as assigned.
Basic Requirements   University degree in a related science (Chemistry).
Minimum 2 years’ experience in the pharmaceutical industry including stability testing and management of stability program.
Acute attention to detail.
Experience working in a self‑directed team environment is essential.
Proven analytical and problem‑solving skills with the ability to make recommendations.
Demonstrated organizational skills with the ability to manage multiple priorities with minimal direction.
Effective interpersonal and communication skills both verbal and written.
Experienced in using Laboratory Information Management System (LIMS) and Microsoft Office is required.
Compensation  Starting at approximately $70,000.00 CAD, with opportunity for increase based on qualifications and experience. Total rewards include comprehensive benefits, bonus eligibility, and professional development support.

What We Offer   Excellent compensation and benefits package
RRSP Program
Discounted gym memberships
Programs supporting work‑life balance (EAP)
Corporate discounts and perks
Employee recognition program
Social events and spirit days
We are committed to diversity and inclusion and thank all applicants in advance; however, we will be corresponding only with those selected for an interview.
In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier‑free recruitment and selection process.

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